PMA P160047S031
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S031
- Product code
- MNB
- Decision date
- 2023-07-28
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for the site change for Mara Probe manufacturing activities.
Current openFDA PMA Record#
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S031
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2023-07-28
- Decision code
- APPR
- Date received
- 2023-06-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the site change for Mara Probe manufacturing activities.